Category Archives: Pharma

Zohydro ban: Disagreeing with Governor Patrick

Massachusetts Governor Deval Patrick is trying to ban Zohydro ER, a new prescription painkiller, under a state of emergency he’s declared to combat opiate abuse. I agree with the Governor that opiate addiction is a huge problem in Massachusetts (and many other places) but the attempt to ban sales of Zohydro is a bad idea that’s likely to have a negligible impact on the addiction crisis while potentially harming one of Massachusetts’ most important industries.

The argument against Zohydro ER (the ER stands for “extended release”) is that it promotes abuse by providing a higher dosage in one pill than comparable immediate release products and that it lacks tamper resistant features that could make the pill harder to abuse. That’s probably why the FDA’s own advisory panel voted overwhelmingly against approval and why the drug has taken so much heat.

Historically states don’t attempt to interfere with the FDA approval process, but Patrick argues that approval is only a minimum requirement for sale and that states are free to impose additional restrictions beyond what the FDA mandates.

Here’s why I think Patrick is misguided:

The drug does address an unmet need and has real benefits

  • It allows some people who need round-the-clock pain relief and who currently use immediate release drugs such as Vicodin to take fewer pills and to avoid Tylenol (aka acetaminophen or APAP) that is typically combined with hyrdocodone and which can harm the liver

The harms presented by this drug are not unique, and the formulation technologies available to deter abuse are not especially effective

  • Some painkillers –such as Oxycontin and Opana ER– have been reformulated to make them harder to abuse, but others including the generic version of Opana ER are available without tamper resistance
  • Search Google for how to defeat tamper proof Oxycontin and you’ll find simple and effective methods to do so. Sure there’s some value to adding such technologies but it’s no cure-all

It would be bad news to establish the precedent that states could place additional restrictions on approved drugs

  • It really perplexes me that Patrick would promote the idea that FDA approval is insufficient to allow a drugmaker to sell its product throughout the US. Is he nuts? It’s a novel idea, laughed at by the first judge –but who knows how other judges will rule and what other states will seek to do if the principle is established
  • It’s expensive and difficult to get a product from lab to market as is. And, regardless of the merits of the Zohydro ER situation, it’s a bad idea overall to make marketing a new drug even harder. Add more uncertainty, cost and hurdles and it will reduce investment in R&D and may eventually have an adverse impact on the availability of new products for patients. Massachusetts is home to many pharmaceutical and biotechnology companies, so I’m especially surprised Patrick would take this step, which is so contrary to the state’s economic interests

The FDA’s decision to approve Zohydro surprised me and many others. It may or may not have been the best decision. But it’s a bad idea for individual states to try to overturn the approval through unilateral actions.

By healthcare consultant David E. Williams of the Health Business Group

Should step therapy and prior authorization be outlawed?


In ‘Fail first’ fails patients in the Boston Sunday Globe, a patient with depression decries his health plan’s use of “step therapy,” which requires members to try less expensive drugs before switching to pricier products.  This is a brave article –the author is going public as a transgender man and as someone who suffers with depression– and I agree that he should not have to endure what he’s been going through. In his case the drug that worked for him was put onto the list of drugs requiring prior authorization. He had to spend endless time with the insurance company and get his doctor to advocate for him to keep him on his therapy.

The author would like to see insurance companies barred from using step therapy and prior authorization, “particularly when insurance companies are still turning profits on our premiums.” That’s a simple solution that will appeal to many readers. After all, the insurance company is standing in the way of what’s best and also inconveniencing the patient and doctor along the way. Yet this solution too simplistic and ignores the broader context in which this situation is unfolding.

As a society we’ve handed health insurers much of the responsibility for controlling costs, while also imposing a series of constraints on them that limit their scope of action. ObamaCare, which I support, takes this approach even further and puts the rest of the US in a similar position to where we are in Massachusetts.

In a more typical insurance business –like life insurance or liability insurance–  the insurance company succeeds by refusing to insure customers who are likely to file claims, increasing rates after claims are filed, and writing policies in such a way as to exclude most things that are likely to happen. There is regulation, but in general you’ll struggle to get life insurance if you’re about to die or if you flunk your medical exam, and your car insurance rates will rise if you get a speeding ticket or cause a crash. In many parts of the country, health insurance has worked like this as well.

But under RomneyCare and now ObamaCare, health plans can’t charge more for people with pre-existing conditions –such as depression– and can’t refuse to accept business even from customers who will definitely be unprofitable. Not only that, but even when insurers do a good job of controlling costs, their profits are capped due to minimum medical loss ratio regulations. If they don’t spend enough on medical costs then the excess premium is returned to the customer.

Before we place yet another restriction on cost containment methods for health plans, let’s look at the broader picture.

First, rising health care costs are a huge problem for employers, individuals and taxpayers. Have your raises been low for the last several years? It’s probably because your employer is paying more for health insurance instead of giving you a salary boost. Is your town having trouble balancing its budget and struggling to find funds to build new schools or hire teachers? A big driver is the rising cost of employee and retiree health care. So it’s really important to bring healthcare costs under control. Step therapy and prior authorization are reasonable ways to do it.

The price differences and impact on premiums are not trivial. The May 2014 issue of Consumer Reports compares prices of drugs before and after they go off patent. Two of the eight drugs on the list (Cymbalta and Abilify) are used for depression. One just went generic and the other will be generic next year. After three years off patent, Cymbalta is expected to cost $27 per month for the generic v. $538 for the brand, and Abilify $45 v. $900. In other words, these drugs will be 95% cheaper once the generic market kicks in. As someone paying insurance premiums, I would rather have someone use a product that costs 5% if it works just as well, including drugs that are generic right now.

Naturally, pharmaceutical companies will push newer, higher-priced products. That’s their job as profit-maximizing companies, and they have a wide array of marketing and sales tools available to them to make it happen. (Unlike health plans, pharmaceutical companies’ profits are not capped.) On the other side, the health plan needs a set of tools to deploy to keep things in balance. In today’s world of biologic drugs that cost tens or hundreds of thousands of dollars it’s prudent to expect most patients to step through a process of trying less expensive treatments first, especially when those treatments may work just as well or better and be less dangerous. If we want –as the author does– to have fully unrestricted access, then that would require some regulation of the price of drugs. Take that too far, however, and the incentive to develop new and innovative medicines will be compromised.

Step therapy and prior authorization are legitimate and even necessary tools. This doesn’t mean that these approaches shouldn’t be scrutinized. In particular, the author implies (although doesn’t come right out and say) that he went through a series of drugs before finding the one that worked for him. If that’s the case, then he shouldn’t be forced to go back and try ones that have already not worked for him. But it’s not clear that this is what’s happening.

Balancing cost, quality, access and convenience in today’s healthcare system is not easy. Making things better requires something more than legislating further restrictions on health insurers.
photo credit: torbakhopper via photopin cc

By healthcare consultant David E. Williams of the Health Business Group

Office of Recovery: Avellone proposes strong response to substance abuse (transcript)

Joe Avellone (D), candidate for Governor

Joe Avellone (D), candidate for Governor

This is the transcript of my recent podcast interview with Joe Avellone, Democratic candidate for Governor of Massachusetts.

David E. Williams: This is David Williams from the Health Business Group. I’m speaking today with Joe Avellone, Democratic candidate for Governor of Massachusetts. We spoke previously about healthcare policy in general. We’re going to speak today about substance abuse.

Joe, it’s great to have you on today.

Joe Avellone: I’m pleased to be here. Thank you.

Williams: Joe, why are you making substance abuse such a high priority issue in the campaign?

Avellone: Well, this is an issue that is quickly becoming a major healthcare crisis in our state. We’ve always had addiction problems, of course, of various types. over our history. But with the development of the new powerful health, the new powerful oral narcotics that had been in the market for the past 15 years, we’ve seen a huge acceleration of young people who are very quickly addicted to these painkillers either by using them recreationally or if it’s just happening or even starting out with sports injuries. And from there, becoming so quickly addicted they move on to other things, in particular, heroin.

And this has been a new phenomenon. Over the past 15 years, the rate of prescribing these drugs had gone up 300% and the rate of actual overdose deaths and prescription pills had gone up 300% in the same time period. So we’re seeing something that is reaching significant public health crisis proportions. It’s really being driven by the use of these powerful oral prescription drugs that then lead to other kinds of addiction.

I have seen the human face of this all throughout the Commonwealth over the last year. I’ve been running for over a year and I’ve been in 130 cities and towns. It really comes up in lots and lots of communities. So it’s affecting lots of communities all across the Commonwealth, certainly in our big cities but also in our smaller towns. And it’s in particular affecting children at relatively young ages in their early to mid-teens. So they first experience this and often are addicted within weeks of starting to take some of these kinds of oral medicines.

Williams:   Talk a little bit more about this heroin issue because I’ve heard this as well. People start with oxycontin or something similar and then when their prescription runs out and they found out how expensive it is to buy those pills on the street, they end up on heroin. Is this just something people say for shock value or is it really happening in any significant numbers?

Avellone: No, unfortunately, it’s really happening in very significant numbers. The addiction potential for these powerful oral narcotics – oxycontin, even Percocet, the other kinds of new opiates – is so strong that within weeks of either experimenting or taking for a mild medical problem, the young people in particular are often addicted. And then, they start down this road of taking them out of their parents’ medicine cabinets or their neighbors, et cetera, and using them at parties. But soon, at $30 a pill, which is about what these things cost on the street, they become so addicted that they move to heroin. And heroin to them does not hold the fear that grips all of us who are a little older. It’s much cheaper than these pills at $7 a bag versus the $30 for a pill. It’s now so plentiful and easier to use than it used to be. So there is a very quick transition and before you know it, you have a lot of young people from middle class families who were playing by all the rules and, all of a sudden, went off the rails with taking these prescription drugs and then end up on heroin within months.

And then, the heroin itself, as you know, ushers in all kinds of other issues especially if it’s using needles. You’re exposed to all the blood-borne diseases and also the heavy addiction and the need to find more heroin.

Williams: Now, clearly, the state’s been paying some attention to substance abuse. What are we doing right and what are we doing wrong on this topic in Massachusetts at the moment?

Avellone: Well, we have a substance abuse department in our public health department and we have a drug monitoring program for these prescription drugs. But all of it is not nearly enough to be effective to combat what is really an epidemic.

And I think that’s the point and that’s why I formed the Office of Recovery. In the end, we’re going to need a lot more capacity. We need to do multiple things that we’re not doing now and we’re certainly not doing on the scale in order to meet the need that is out there.

Williams: Have you seen other states or other countries that are doing things better? Are we a laggard here or is it just that the problem has come up so quickly that others have not come up with a good response either?

Avellone: No, I don’t think we are a laggard in the traditional sense. I think if we’re viewing this as a traditional problem at the level that which we all thought it was affecting our population, our Bureau of Substance Abuse is doing an adequate job. But that is not where we are. What is happening is this is mushrooming, it’s affecting many more people. And we are not at all treating it in the way that we should: dealing with it as a crisis, which is really what it is.

Williams: You’ve announced a plan for this area. What are its key components?

Avellone: I’ve announced the formation of Office of Recovery. This will have to be at the state level because it affects so many towns and cities across our Commonwealth.  It has to be high in the Office of Health and Human Services, so it will be a direct report in the Executive Office. We’ll take in the current Bureau of Substance Abuse because those traditional roles that are being played there would need to continue, but we need to expand it.

The Office of Recovery will, first of all, increase our capacity. We do not have nearly enough capacity to deal with either detox or rehab or the sober houses along the spectrum. We need to reimburse our providers more to bring more capacity on line. Increasing capacity is the first part of this.

This Office will have a whole series of regional coordinators that will, in a very publicized way, make it possible for people to have one number to call and they know to call this number when they need treatment. One of the problems of intervention is making sure that the treatment is available and that people can get into treatment right when they need it, right when that window is open.

And we know that window’s not open very long. People, when they finally get the resolve that they can actually treat themselves, they have to move on to make a big change and we need to find them and they need to find treatment then. And that’s what the regional coordinators will do.

In addition, I’d like to staff them with people who’ve been in recovery. There’s a large recovery community that can be very helpful to people who are suffering from addiction and really help them clear the course and get into treatment.

In addition to standing capacity and the regional coordinators, we need to change the way insurance coverage works. Right now, part of the problem is gaps in insurance coverage and slow approvals. And that, once again, creates roadblocks in the system where people are stuck in detox because they can’t get to rehab or they’re stuck in rehab because they can’t get into the next step. Or they have to wait for approvals and if the approvals don’t come, once again, they fall back into their addiction and are lost.

Another key component of this is to move away from putting minor drug offenders in jail. Right now, we have many thousands of people in our county jails; about 75% of them are there for drugs or drug-related problems; and a large percentage of those are addicted. The males are in jail in these county jails for approximately a year, and they cost about $46,000 a year. If we were not putting people in jail and were using that money differently, which we will in my administration, that would cover a lot of treatment.

The vehicle for doing this is drug courts. We have about 21 drug courts around the Commonwealth. We need to have about 50, people estimate. We need to make sure we have it in every jurisdiction. These drug courts operate specialized programs that help people not only not go to jail but then move through their recovery and guide them through their recovery. Specialized courts cant do that.

And finally, we need to much more aggressively step up our drug monitoring. We do have a drug monitoring program but obviously, the prescribing patterns are not what they should be. We are over-prescribing either wittingly or unwittingly in a large amount. There are so many of these pills sitting around unused in medicine cabinets. That’s how the diversion occurs, especially with these young people.

I have heard so many stories from mothers and parents of addicted children, of the fact that they were getting prescriptions for wisdom teeth or other relatively minor ailments that they don’t even want. They have so many pills and would have these pills sort of sitting around. And this is a big problem.

So we have to be much more vigilant about our prescribing practices. I’m going to work with the Massachusetts Medical Society on education programs and also with the Board of Registration in Medicine to make sure we have people who are knowingly prescribing the things that they are appropriately dealt with.

So, these are the major components of my Office of Recovery but I want to go beyond that. I think we need to deal with this as a region as well.

Williams: Joe, we’ve been talking mainly about how these prescription narcotics are causing problems in terms of addiction leading to heroin. I want to ask you about two other substances and how and if they fit in here. One is alcohol, the other marijuana. I’ll separate those out.

Alcohol, often people talk about the large impact that it has relative to higher profile and scarier sounding substances. And then on marijuana, we seem to be on a path toward outright legalization as we’ve seen elsewhere, which seems to be going sort of in the opposite direction from a public health standpoint.

How would you view those substances fitting into the Office of Recovery?

Avellone: I think alcohol should be incorporated in that. I spent a fair amount of time in the treatment facilities, for example, the Dimock facility in Roxbury and also SSTAR, which is a wonderful facility in the Fall River area. And clearly, they treat alcohol as an addictive substance like the other drugs that they deal with. There are some differences but they accommodate those differences in the program. It clearly destroys lives just as surely as these powerful opiates do. So I do think that this is part of our issue and a problem that ought to be addressed to the Office of Recovery.

I feel a little bit different about the marijuana. I don’t think that would be the main focus of this right now because I want to deal with the more powerful and addictive drugs that are essentially killing people and ruining lives and destroying families right now. And that’s why, alcohol and in particular, these opiates, especially prescription drugs and then heroin.

Williams: When you put these plans in place for the Office of Recovery, what would be realistic or aspirational to expect the impact to be? Is it possible to really take this problem on or are we really just talking about taking a little bit off the edges of it?

Avellone: No, I think it really is possible. I think we have to understand how acute the problem is right now. Now, just to deal with the overdose deaths alone, which is certainly the tragic end state of this, we have had 11 overdose deaths per 100,000 of the population. So, that’s over 600 a year. And we know that’s just the tip of a very large iceberg of people whose lives are destroyed or being destroyed but are living and going through a living hell every day.

But just dealing with overdoses, those are the statistics. They’ve gone up to 11 per 100,00 from 7 1/2 per 100,000 just ten years ago. So, it’s rising rapidly. That’s a big change. We heard about the fact that we had 185 overdose deaths just in the last three or four months, and we know that was a very incomplete number because it didn’t even deal with Boston and Springfield, our major metropolitan areas. We know that even at 11 per 100,000, which has been released as statistics, it’s certainly going to be more than that next year and rising relatively rapidly.

So, I know this is an issue that we can definitely, if we treat it aggressively, do something right. We know that treatment plan works and we also know that right now, we’re not treating it adequately at all.

The biggest thing of all the Governor can do and which I would certainly do is to take the stigma away from addiction. I think part of why we treat this inadequately and why people don’t seek treatment is because of our attitude about it.

However, I think we now recognize that this is a health problem and this is something that the Governor needs to take the lead in. It’s not a moral issue. It’s a health issue and we have to treat it that way. If we can remove the stigma, then a lot of things become easier. Getting people into treatment, moving people away from jail sentences and enabling people to rebuild their lives, which they can if we can get them the right treatment.

Williams: Joe, you talked about the societal cost here and even some hards cost in terms of the cost to incarcerate someone. But in setting up an Office of Recovery like this, I’m sure there are new budgetary expenditures that are needed. What’s the order of magnitude of those and how do you finance such an effort?

Avellone: The cost is about $1,000 per person but the benefit to cost ratio of treatment is huge. Many studies show that it’s something like seven to one. And those benefits come from several different sources. First of all, let’s just start with jail. Right now, we’re putting literally thousands of mostly young people in jail for minor drug offenses related to their addiction. That’s at $46,000 a year because as I said, in the county jails, the males are there for about a year.

If we just, next year, incarcerate 500 less, then that’s a fraction of the 10,000 people that are in the county jails. That’s $23 million plus for treatment. So that covers an awful lot of treatment. Literally, incarcerating people less almost covers the whole total cost of the treatment. In addition to that, the healthcare cost is much less. If people are successfully treated, there are many fewer trips to the emergency room and they have many fewer other high costs due the healthcare issues that the population with addictions have.

So this is more about moving money in the budget that we already have because of new expenditures that we’re not incurring. And I believe that we can do this without a big increase in the budget. That’s why it has to be done as a high priority in the Governor’s Office because it’s going to take moving dollars away from some parts of our budget and into others. And doing that in a very, I would say, calculated way. It’s going to take leadership to do it but I think the analysis will bear us out that we can move the dollars and accomplish much.

Williams: Joe, you have been having a quite a comprehensive discussion here about issues of substance abuse in a Commonwealth and in your plans that will be able to address it. Are there topics that we have not addressed that we should do today?

Avellone: Thank you, David. I would like to talk about the regional initiative I’m proposing. I’m going to, once elected, pool together the other Governors and the whole Congressional delegation in the region. So with six states – that’s six governors, 12 senators and 21 congressmen – I believe that we can be more successful in some respects with this operating as a regional initiative.

And the first is to go put a lot a pressure in the FDA. The FDA needs to have a much higher safety profile when approving new narcotics. And I think this is a failing. I think they were essentially suffering now from something that they should have done ten years ago. I think going forward, we have to make sure that they’re not approving narcotics that are powerfully addictive and yet easily available. That really is what has led to this great acceleration.

I also believe we can put some pressure on the pharmaceutical industry as well.

As a region, we have a lot more clout to deal with the FDA and with the pharma industry. I also think we can work together to cut down on the smuggling of heroin. The second half of this is the fact that heroin is so available and young people in particular moved to it as prescription drugs become harder to find than the heroin. We need to shut down the heroin pipeline and I think we can do that more effectively as a region.

I think also as a region we can learn best practices from each other and potentially even share facilities to deal with the ups and downs of our capacity needs. So, I believe this is something that we can effectively treat as a region and I intend to lead our efforts to do that.

Williams: This is David Williams of the Health Business Blog. I’ve been speaking today with Joe Avellone. He’s been talking about substance abuse and has proposed an Office of Recovery to address these issues.

Joe, thank you so much.

Avellone: Thank you very much, David. It’s my pleasure to be here with you.

By healthcare consultant David E. Williams of the Health Business Group

Hooray for high-priced hepatitis treatment Sovaldi

Congratulations to Gilead Sciences for producing Sovaldi (sofosbuvir), which cures hepatitis C about 90 percent of the time. The drug has a list price tag of $84,000 for 12 weeks of treatment. That $1000 per pill price tag is causing concern among health insurers, policymakers and the general public. The Wall Street Journal (Sales Soar for Pricey Hepatitis Drug Sovaldi) emphasizes the negative impact the drug’s release is likely to have on health insurers’ profits this year.

Doctors and patients are rushing to embrace the drug, and prescribing has taken off during the first several months of availability. Despite the concerns about cost containment, health insurers and pharmacy benefit managers have done little to restrict access. Gilead is making money hand over fist.

This is the American healthcare system at its best: providing rich rewards to those who bring truly innovative solutions to market first and not letting cost concerns lead to rationing. I hope Gilead’s example spurs investors to fund other treatment breakthroughs and get them to market ahead of competitors. 

Hepatitis C is a scourge and the treatments have been difficult to take and not nearly as effective until now. One of the reasons the total costs of Sovaldi is so high is that there are millions of people who were infected years ago and are starting treatment now. The CDC recommends testing for baby boomers, many of who were unknowingly infected from intravenous drug use in the 60s and 70s or from a tainted transfusion received up till the early 1990s. Once the big group of long-term infected patients is tested and treated, and when more products like Sovaldi come to market, costs will decline.

The cost problem in American healthcare is not from products like Sovaldi that are expensive but work. The problem is expensive care that is less effective or even harmful.

I asked all nine candidates for Governor of Massachusetts the following question:

Hepatitis C is 3 or 4 times more common than HIV. New drugs that can cure the infection are coming on the market this year but they are very expensive. What role should the state play in ensuring that residents are tested, linked to care, and have access to these new medications?

Don Berwick, former head of CMS and the Institute for Healthcare Improvement, had a good answer:

“We have to recover money from ineffective care, wasteful care, and harmful care.  We need to work very hard to make sure that we have the resources liberated from health care waste, so we can rededicate them to things like proper hepatitis C care.”

None of the candidates had a great suggestion for how to make sure everyone gets tested. But the beauty of the profit motive is that Gilead is hard at work raising awareness about hepatitis C testing and treatment, which will benefit the company and patients.

By healthcare consultant David E. Williams of the Health Business Group

Office of Recovery: Avellone proposes strong response to substance abuse

Joe Avellone (D), candidate for Governor

Joe Avellone (D), candidate for Governor

Dr. Joe Avellone, Democratic candidate for Governor of Massachusetts, is very concerned about the impact of substance abuse. In particular, he’s zeroed in on addictions to narcotics and heroin that have arisen out of the widespread prescribing of powerful painkillers for serious and not-so-serious conditions.

His Office of Recovery would have high visibility in the Executive Office of Health and Human Services and focus on getting individuals into treatment during their window of opportunity.

In this podcast interview, Avellone describes why he’s making this issue a priority, how his plan would work, and how it compares to efforts elsewhere.

Earlier I interviewed Avellone and all other candidates for Governor about healthcare policy.

By healthcare consultant David E. Williams of the Health Business Group

A better business model for antibiotics

For the past couple of decades antibiotics have generally been a low margin, low revenue business that big pharma has stayed away from. Lack of new drug development activity combined with an increase in antibiotic resistance and the rise of “superbugs” are leading us rapidly to a frightening place where we lack effective drugs to stop many dangerous infections.

A Wall Street Journal article (Drug makers tiptoe back into antibiotic R&D) provides the welcome news that drug makers are starting to invest in this area again. One reason: they are hopeful that when the new products get to market there will be a greater willingness to pay than there has been historically. Antibiotics can have a big payoff in the form of improved quality and length of life and avoided medical costs. Curing an infection in one person can also prevent others from getting it.

The article speculates about reimbursement from health plans and whether big insurance companies will be willing to pay more for new antibiotics than they have for old ones. The answer may be yes, but I’m not sure it’s the relevant question. I’m reasonably optimistic that in the new world of global capitation, accountable care organizations, and other methods for placing risk on providers that the providers themselves will be willing to pay because it will be a net positive for them financially.

There’s also a brief mention of introducing a licensing model for drugs based on number of patients and indications rather than quantity of product. I think that’s a great idea and have written about it in the past.


By David E. Williams of the Health Business Group.

Marijuana legalization: Con and pro

Reefer Madness

I’m flying home from Colorado, where marijuana became legal for recreational use earlier this month. I didn’t see anyone lighting up but there was certainly a bit of a buzz in the air about it. In Massachusetts, too, marijuana is becoming less illegal –with decriminalization followed by medical use. I wouldn’t be surprised to see full legalization coming, too.

I have to admit I’m a little surprised that the pro-pot faction is making so much headway. And a little disappointed, too. I won’t invite comparisons to Reefer Madness by sounding too alarmist, but clearly marijuana is not good for you.  It seems to me that in an era where cigarette distribution is becoming more restricted and people are becoming more conscious of what they eat and how they take care of their bodies, marijuana would be getting less popular not more.

If marijuana has valid medicinal uses then it should be tested and approved like any other drug. And if clinical trials show it doesn’t work then it should be off the market. I expect that in a few years, if marijuana use soars as I think it might, we might have a situation similar to what we’re witnessing with narcotic painkillers now. In other words, we’ll be regretting that we were too sanguine about the use of these products but that it’s hard to put the genie back in the bottle. Dr. Mitchell Rosenthal has a good op/ed piece in the Wall Street Journal today in which he lays out the various dangers of weed.

Having said that, I do favor decriminalization of marijuana. Getting busted for pot shouldn’t land a person with a criminal record, which could ruin their life by ruining their job prospects. But perhaps the most compelling reason for decriminalization is that it ends the incentive for the police and federal authorities to seize assets –like houses, land and cash– to use for their own purposes. The police should not have those kinds of incentives in place. The Wall Street Journal has a good piece on this as well.

photo credit: kat st kat via photopin cc

By David E. Williams of the Health Business Group.

Like I said: Advair Diskus too hard to copy

Generics maker Teva confirmed it doesn’t expect to bring a generic version of Advair to market before 2018, even though patents are expiring sooner. The reason for the delay: the inhaler device is too hard to replicate.

As I wrote last month (How a tough manufacturing process for Advair might help GSK):

Unlike the typical round, white pill, its complex inhaler mechanism was never designed to be produced in huge quantities in multiple locations around the world, where different environmental conditions and variations in raw materials could make it hard to duplicate. So manufacturing has been a challenge for GSK and consumed plenty of resources…

So ironically, due to GSK’s inability to anticipate the high demand for Advair and develop an easier-to-make device, the company is now benefiting from a much stronger barrier to entry on its lead product than it could ever have imagined or hoped for.

GSK got incredibly lucky with Advair. It now looks like that luck will continue.

By David E. Williams of the Health Business Group.

How a tough manufacturing process for Advair might help GSK

When GSK introduced its Advair Diskus to the market about 15 years ago, it wasn’t expected to be such a big hit, never mind reaching close to $8 billion in sales as it did last year. It’s actually not so abnormal for demand for new drugs to be way off their initial projections and it’s typically no big deal. If a drug is unexpectedly popular it may take a while for production to ramp up but then the problem is usually over.

But Advair is a different beast. Unlike the typical round, white pill, its complex inhaler mechanism was never designed to be produced in huge quantities in multiple locations around the world, where different environmental conditions and variations in raw materials could make it hard to duplicate. So manufacturing has been a challenge for GSK and consumed plenty of resources.

The pharmaceutical world of 2013 looks a lot different than it did in the 1990s. Advair is now GSK’s biggest product and the pipeline of potential blockbusters does not look all that promising. A normal product would have had plenty of generic competition by now, but GSK has managed to hold onto the whole market. The reason: prospective generic competitors struggle at least as mightily as GSK –and with fewer resources– to produce the darn thing. The FDA is moving, but slowly, to clear a path for generics. It’s still not clear when and if such copies will be available.

So ironically, due to GSK’s inability to anticipate the high demand for Advair and develop an easier-to-make device, the company is now benefiting from a much stronger barrier to entry on its lead product than it could ever have imagined or hoped for.

The strategy looks brilliant in retrospect. If pharma developers are smart they’ll try to pull off something similar with their next launch.

Rerun: What the Talmud teaches about drug company gifts to doctors

In honor of the Jewish New Year I’m re-running a post on Judaism’s insights into pharmaceutical sales and marketing practices. L’shana Tova!

Recently I heard a Rabbi discuss the prohibitions against bribes in Jewish law. He shared the Talmudic insight that “a gift blinds the eyes of the wise” and taught that this refers not just to obvious bribes but even to small, innocent-seeming gestures that appear too insignificant to influence another person but that actually do cause a conflict of interest. I told him this sounded very similar to contemporary relationships between pharmaceutical companies and prescribing physicians, where small gifts like pens and take-out lunches are tools of the trade –viewed as innocuous by their recipients but seen as a good investment by the givers.

I revisited a blog post I wrote on the topic back in 2006 along with a JAMA article (Health industry practices that create conflicts of interest: a policy proposal for academic medical centers) by Brennan et al. from the same era. I looked at the list of articles citing the Brennan piece to see if I could find something more current. Lo and behold I discovered Unconscious conflict of interest: a Jewish perspective by Gold and Applebaum in the Journal of Medical Ethics, which probes this issue in more depth. They write:

The Talmud [Tractate Kethuboth folio 105b] suggests that, due to the unconscious mechanism of influence between the giver and the receiver, the prohibition of receiving a gift is not limited to physical gifts, but extends to any other personal benefits, including ‘a bribe of words’:

Our Rabbis taught: ‘And thou shalt take no gift’; there was no need to speak of [the prohibition of] a gift of money, but [this was meant:] Even a bribe of words is also forbidden, for Scripture does not write, ‘And thou shalt take no gain.’ What is to be understood by ‘a bribe of words’? –As the bribe offered to Samuel (a Talmudic scholar who served as a judge). He was once crossing [a river] on a ferry when a man came up and offered him his hand. ‘What,’ [Samuel] asked him, ‘is your business here?’ –‘I have a lawsuit,’ the other replied. ‘I,’ came the reply, ‘am disqualified from acting for you [ie, as a judge] in the suit.’

In a meticulous reading of the story mentioned above, it is not clear whether Samuel, the Talmudic scholar, actually accepted assistance from that ‘courteous’ man. In fact, his reaction of disqualifying himself from serving as a judge seems to be related solely to the man’s offer. That man’s gesture –offering his arm– was a sufficient cause for the disqualification. The gesture alone was perceived by Samuel as a sort of speech-act that emanated –perhaps unconsciously– from the man’s desire to influence his judgement. In other words, the offering of the arm was ‘a bribe of words’.

To me this is fascinating stuff and suggests that to truly avoid the unconscious conflict of interest in the pharma/physician relationship it would be necessary to cut off all contact between pharma rep and doctor. Even when a drug rep is prohibited from distributing tsotchkes or tapping his restaurant budget, the physician still knows the rep would give him things if he could. Under this logic, the “no see” policies of some physician organizations toward pharma reps make good sense.

There is another solution, which is to educate physicians about unconscious biases and the objectives and tactics of pharma companies, device companies, health plans, and other would-be influencers. Even better would be to couple this education with conscious efforts to counteract any biases that are introduced.

Physicians are notoriously skeptical of the notion that they are influenced by gifts large or small. Therefor the article wisely concludes:

For those disinclined to accept either the insights of sociologists and anthropologists or the findings of modern neuroscience on the tendency towards reciprocity in response to the receipt of gifts and favours, perhaps the wisdom of the ancients provides a reason to rethink the unconscious influence of even small benefits on physician behavior.